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TR: As you describe it, personalized medicine will involve both tests for genes or proteins that might cause a person problems, and medicines tailored to that person and those genes or proteins. But right now aren’t we in a somewhat uncomfortable phase where we have some of the tests, but few of the medicines?

Levin: You are right-for the most part the tests have been out there first. But the field is changing rapidly-a new therapy for breast cancer is now personalized to the woman based on her expression of a particular protein. Products that Millennium develops going forward will in most cases have a test and a therapy together. Over the next five to 10 years, we’re going to see an explosion of not only these tests, but the integration of tests and therapy for personalized medicine.

TR: Whenever one of these tests comes out, particularly when it’s a gene-based test, there are questions about privacy. Is that something you take into consideration?
Levin: We absolutely do. Our chief business officer, Steve Holtzman [Holtzman has since left that position and acts as an advisor to Levin], was on President Clinton’s council for bioethics, and has been very involved in developing policy for the government with regard to privacy. We also recently opened a government relations department in Washington, DC. We believe in order for personalized medicine to be important in the future, one’s rights have to be protected.

TR: Does personalized medicine throw a monkey wrench into the economics of drug development? After all, if you’re making treatments tailored to patients with a specific genetic profile, aren’t you limiting the market for each new drug?
Levin: Well, it does and it doesn’t. Many products that would have actually failed in the past, because they were toxic on a very small percent of people, will now become very important products for the future because of the ability to determine who should and should not get the drug. Secondly, you’re going to get into the clinic and to the marketplace quicker because picking the patient population most likely to benefit for clinical trials will make it easier to prove a drug’s efficacy. Thirdly, when we get into the marketplace, products will have more activity and less side effects than today’s drugs, thereby being of higher value. And it is also important to remember that when a patient is put on a drug today, 20 to 40 percent of the people are taking a drug that will not work for them.

TR: Are doctors ready for personalized medicine?
Levin: It’s an important question. If we go back five to 10 years ago and look at the education for doctors, there was almost no training in genetics. Doctors were not getting the kind of training they needed to have a real understanding of how important these technologies are. Today, when you go into medical schools, you see much more integration of genetics and molecular medicine. Every day, we are meeting more doctors in academia and in practice who are very interested and beginning to implement personalized medicine.

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